The Josep Carreras Foundation promotes the new Advanced Therapies Unit at the Hospital de Sant Pau

On 17 June, the foundation stone was laid for the new Advanced Therapies Unit at the Sant Pau Research Institute (IR Sant Pau), known as the clean room. This new facility has become a strategic resource, as it will enable the development and manufacture of personalised biological drugs for oncohaematological patients to be increased.

The event was attended by various personalities from the sector, the Honourable Manel Balcells, Minister of Health (in functions); the director of the IR Sant Pau, Dr. Jordi Surrallés; the president of the Delegate Commission of the Josep Carreras Leukaemia Research Institute, Dr. Evarist Feliu; the head of the IR Sant Pau; the director of the IR Sant Pau; the president of the IR Sant Pau; the head of the IR Sant Pau’s research department, Dr. Evarist Feliu; head of the research group of the Josep Carreras Institute and the IR Sant Pau and director of the Haematology Service of the Hospital de Sant Pau, Dr. Javier Briones, and the director of the Hospital de Sant Pau, Dr. Adrià Comella.

“This infrastructure is an asset that will not only serve other research centres in Catalonia and Spain, but will also open the door to establishing international collaborations with other centres around the world for the benefit of many patients and the advancement of knowledge in this area,” adds Dr. Surrallés.

The Josep Carreras Foundation has provided more than 4.5 million euros for its construction, equipment and start-up. With this project, the Sant Pau Campus of the Josep Carreras Leukaemia Research Institute was created with the aim of carrying out scientific research activities related to cancer, leukaemia and other haematological malignancies, especially in immunotherapy, oncogenesis, cell therapy and other related areas.

In addition, the new Advanced Therapies Unit has the support of the Blood and Tissue Bank (BST), which provides the new unit with professional expertise and manufacturing capacity for advanced therapy drugs, as part of a recently signed collaboration agreement aimed at boosting the development and production of innovative drugs.

World-class infrastructure

The new facility will grow from 39m² to 163m², and will have four highly complex cleanrooms to conduct research.

Clean rooms are designed and controlled spaces for high-precision biomedical research. Strict hygiene and cleanliness protocols are established, controlling temperature, humidity and air pressure. The air is constantly filtered to remove particles and micro-organisms.

The new facilities will boost the important work of research groups that are working to develop new advanced therapies, such as the one led by Dr. Briones in the field of haematology. “This new infrastructure puts us at the forefront of research in this field and will help us move more quickly towards more effective and personalised treatments for our patients and continue to contribute to the advancement of scientific knowledge”.

Advanced therapies: increased production capacity

Sant Pau’s new Advanced Therapies Unit will not only allow for greater drug production, but will also centralise the entire development process within the institution itself. This will ensure greater efficiency and quality control throughout the process.

Dr. Briones remarks that “the new unit will not only increase our production capacity, but will also allow us to conduct clinical trials in their entirety from start to finish, with all the advantages that this entails”.

“This is a dream come true. We have been working in immunotherapy for more than 20 years, and for the last 10 years we have focused on CAR-T therapies. This new unit will allow us to increase our production capacity and reach more patients, offering personalised treatments for diseases that until now had no cure,” says Dr. Briones.

Sant Pau is one of the two hospitals authorised in Catalonia – and one of the few in the world – to produce CAR-T immunotherapy drugs. “There are very few centres in the world that make their own CAR-T, that is, that have the technology and the capacity, experience and facilities to be able to develop this type of therapy,” says Dr. Briones. So far, IR researchers have developed two academic CAR-T drugs: HSP-CAR30 and HSP-CAR19M.

CAR-T immunotherapy

The Cellular Immunotherapy and Gene Therapy research group at the IR has so far developed two academic CAR-T drugs: HSP-CAR30 and HSP-CAR19M, with an ambitious project led by Dr. Briones.

The Josep Carreras Leukaemia Foundation and the Josep Carreras Leukaemia Research Institute also strongly supported the HSP-CAR30 project with the acquisition of an important part of the equipment and the provision of funds for phase I drug production.

HSP-CAR30 is currently in phase II clinical trials and is the first CAR-T30 immunotherapy drug (academic) in Europe.

In phase I, CAR30 memory T-cells (HSP-CAR30) were shown to have an excellent safety profile, i.e. very low toxicity, as well as high efficacy, with 50% of patients having a complete response to treatment with disappearance of the lymphoma.

“CAR-T30 is the first CAR-T30 to be developed in Europe, and there are only three others in the world, in the United States and China. We are proud to be able to develop this type of therapy and, most importantly, to be able to offer it to our patients. Moreover, as it is currently the only CAR30 developed in Europe, we also treat patients from other countries. This is a source of pride and professional enrichment for us, as it gives us the opportunity to generate knowledge,” adds the expert.